Comparison of Abbreviated Breast MRI and Digital Breast Tomosynthesis in Breast Cancer Screening in Women With Dense Breasts
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,516
- 试验地点
- 68
- 主要终点
- Screen-detected Invasive Cancer Verified by Pathology
研究概览
简要总结
This randomized phase II trial studies how well abbreviated breast magnetic resonance imaging (MRI) and digital tomosynthesis mammography work in detecting cancer in women with dense breasts. Abbreviated breast MRI is a low cost procedure in which radio waves and a powerful magnet linked to a computer and used to create detailed pictures of the breast in less than 10 minutes. These pictures can show the difference between normal and diseased tissue. Digital tomosynthesis mammography is a procedure that uses multiple x-rays pictures of each breast to produce a 3-dimensional rendering of the entire breast. Combined screening with abbreviated breast MRI and digital tomosynthesis mammography may be a better method to screen women with dense breasts.
详细描述
PRIMARY OBJECTIVES:
I. To compare the rates of detection of invasive cancers between the initial abbreviated breast (AB)-magnetic resonance (MR) and digital tomosynthesis mammography (DBT).
SECONDARY OBJECTIVES:
I. To compare the positive predictive value (PPV) of biopsies, call back rates, and short-term follow up rates after AB-MR and DBT on both the initial and 1 year follow up studies.
II. To estimate and compare the sensitivity and specificity of AB-MR and DBT, using the 1 year follow up to define a reference standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patents must be scheduled for routine screening DBT
- •Women must not be pregnant or breast-feeding; all females of childbearing potential who are uncertain if they could be pregnant or may be pregnant or as per local site standard of practice in women undergoing DBT and MRI must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- •Women of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the following year until the year 1 AB-MR and DBT studies are performed
- •Patient?s breast density must be known; patients must have mammographically dense breasts, American College of Radiology [ACR] Breast Imaging [BI]- Reporting and Data System Atlas (RADS) lexicon categories c or d (heterogeneous or extreme fibroglandular tissue) on their most-recent prior screening
- •Patient must be asymptomatic for breast disease and undergoing routine screening
- •Patient must have no known breast cancer (DCIS or invasive cancer), not currently undergoing treatment for breast cancer, or planning surgery for a high risk lesion (atypical ductal breast hyperplasia [ADH], atypical lobular breast hyperplasia [ALH], lobular breast carcinoma in situ [LCIS], papilloma, radial scar)
- •Patient must not be taking chemoprevention for breast cancer
- •Patient must not have undergone breast ultrasound within 12 months prior to randomization
- •Patient must not have previously had a breast MRI
- •Patient must not have previously had molecular breast imaging (MBI, multiplexed ion beam imaging [MIBI])
- •Patient must agree to not undergo screening ultrasound (of breast) for the duration of the 1 year study period
- •Patient must not be suspected of being at high-risk for breast cancer, as defined by the American Cancer Society (ACS) breast MR screening recommendations (lifetime risk of >= 20-25%)
- •Patient must be able to undergo breast MRI with contrast enhancement; patients unable to undergo breast MRI with contrast enhancement for any reason are ineligible
- •No history of untreatable claustrophobia
- •No presence of non MR compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication
- •No history of sickle cell disease
- •No contraindication to intravenous contrast administration
- •No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance
- •No known or suspected renal impairment; requirements for glomerular filtration rate (GFR) prior to MRI as determined by local site standard practice
- •Weight less than or equal to the MRI table limit
- •No women who have had prior contrast enhanced mammography (contrast enhanced spectral mammography [CESM] or contrast enhanced digital mammography [CEDM])
- •No women who have breast prosthetic implants (silicone or saline)
排除标准
- 未提供
研究组 & 干预措施
Arm B (AB-MR, DBT)
Participants undergo AB-MR for under 10 minutes followed by DBT on the same day or within 24 hours at baseline and then after 1year.
干预措施: Digital Tomosynthesis Mammography (Diagnostic Test)
Arm B (AB-MR, DBT)
Participants undergo AB-MR for under 10 minutes followed by DBT on the same day or within 24 hours at baseline and then after 1year.
干预措施: Contrast-enhanced Magnetic Resonance Imaging (Diagnostic Test)
Arm A (DBT, AB-MR)
Participants undergo DBT followed by AB-MR for under 10 minutes on the same day or within 24 hours at baseline and then after 1 year.
干预措施: Contrast-enhanced Magnetic Resonance Imaging (Diagnostic Test)
Arm A (DBT, AB-MR)
Participants undergo DBT followed by AB-MR for under 10 minutes on the same day or within 24 hours at baseline and then after 1 year.
干预措施: Digital Tomosynthesis Mammography (Diagnostic Test)
Arm A (DBT, AB-MR)
Participants undergo DBT followed by AB-MR for under 10 minutes on the same day or within 24 hours at baseline and then after 1 year.
干预措施: Quality-of-Life Assessment (Other)
Arm A (DBT, AB-MR)
Participants undergo DBT followed by AB-MR for under 10 minutes on the same day or within 24 hours at baseline and then after 1 year.
干预措施: Questionnaire Administration (Other)
Arm B (AB-MR, DBT)
Participants undergo AB-MR for under 10 minutes followed by DBT on the same day or within 24 hours at baseline and then after 1year.
干预措施: Quality-of-Life Assessment (Other)
Arm B (AB-MR, DBT)
Participants undergo AB-MR for under 10 minutes followed by DBT on the same day or within 24 hours at baseline and then after 1year.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Screen-detected Invasive Cancer Verified by Pathology
时间窗: Up to 1 year
For each modality, the detection rate of invasive cancers is defined as the proportion of participants who had an invasive cancer detected by the modality at baseline and verified by pathology versus the total number of participants. In the out come measures table below, these proportions will be automatically calculated, multiplied by 100, and be presented as percentages (%).
次要结局
- Positive Predictive Value (PPV) of Biopsies(Baseline to up to 1 year)
- NanoString Tumor Biologies of Invasive Cancers and Ductal Carcinoma in Situ (DCIS) Detected on AB-MR and DBT(end of study)
- Factors Associated With Willingness to Return for Screening(Up to 1 year)
- Call Back/Additional Imaging/Short-term Follow Rates for DBT and AB-MR(Baseline)
- Prediction of Breast Cancer (Sensitivity and Specificity)(Baseline to up to 1 year)
- Willingness to Return for Testing With Abbreviated Breast-magnetic Resonance (MR) Versus Digital Tomosynthesis Mammography (DBT)(Up to 1 year)
- Oncotype-DCIS Scores by Modality(Up to 1 year)
- Change in Patient-reported Short-term Quality of Life Related to Diagnostic Testing(Baseline to up to 1 year)
- Incident Cancer Rate(Up to 3 years)